BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3029077 · Received April 1, 2013

    Report

    Report Number
    6000034-2013-00612
    Event Type
    Injury
    Date Received
    April 1, 2013
    Date of Event
    March 20, 2013
    Report Date
    November 25, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNAVAILABLE FOR ANALYSIS. CORRECTION: THE CORRECT PMA IS K984162 NOT K955713 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED APRIL 4, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW FIXTURE/ABUTMENT ON (B)(6) 2013. CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6); NOT (B)(6) AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT MODEL # OF THE DEVICE IS 92128; NOT 93330 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS ON (B)(6) 2013. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131446 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 94965

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention